Are Patients making off-label Use of Anti-Retrovirals (ARVs) for Treating Chronic Fatigue Syndrome?

Results of a Quick Poll on off-label use of Anti-retrovirals for treating Chronic Fatigue Syndrome. Details Below.

Antiretroviral therapy in Chronic Fatigue Syndrome (CFS) patients can be a touchy subject. Last week I blogged about an article by the New York Times columnist Scott James that hit a nerve in the CFS community last week when he reported on the use of HIV drugs by some CFS patients. The column however lacked hard numbers and evidence leaving many questions unanswered. The biggest question was whether the column revealed a trend or documented a rare regional situation. And so the story continues.

Getting to the heart of the debate

At the heart of the discussion, in my opinion, was whether CFS patients, who needed financial assistance from drug companies to take HIV drugs to treat an as yet scientifically unverified retrovirus infection, were depriving HIV patients who also needed assistance of the lifesaving drugs. The column assumed that Gilead Sciences Inc. , a company that manufactures several HIV drugs, was marketing their drug to CFS patients. However, Mr James stated in an email that he did not have verification of such speculation and the company stated that CFS is not one of the diseases for which they give financial assistance. Dr. Michael Snyderman who is himself taking antiretrovirals, and paying for them from his own funds, puts the blame on the manufacturer. “This very sick population of patients is being blamed for a shortage of HIV drugs. I find this repugnant. The drug companies have the ability to ramp up production, but chose not to do so because of profit margins.”

There was one CFS patient quoted in the column as obtaining HIV drugs through the manufacturer’s financial assistance program and Mr. James in the same email stated that he had been contacted by other CFS patients also taking antiretrovirals, but did not say whether the patients paid for the drugs themselves.

The Science in 2009

In 2009, the promise of antiretrovirals looked bright following the publication of a paper in Science associating a retrovirus known as XMRV with CFS. Earlier studies had associated it with prostate cancer and in vitro studies showed that raltegravir and tenofovir among other drugs were effective against XMRV. The authors concluded that should XMRV prove to be a causal factor in prostate cancer or CFS, these discoveries might allow for rational design of clinical trials.

However, over the next two years, study after study in both prostate cancer and CFS were unable to find an association between the diseases and XMRV dimming the prospects of an easy answer. Although the results of another study are anticipated in the next few weeks, and the NIH has yet to weigh in with their XMRV study, most scientists believe the writing is on the wall. Several weeks ago the authors of the Science paper partially retracted the paper after a collaboration of many scientists could not substantiate the initial findings.

Results of the Cure Talk CFS Poll

Frustrated and deeply disappointed many, but not all, CFS patients reluctantly considered the chapter closed.

So on behalf of Cure Talk, I reached out to patients to see if the assumptions made were true. We fielded a quick a poll in a large patient website, Phoenix Rising. The poll was viewed by approximately 100 patients of which seven participated. It was a simple one question poll with multiple choices to ascertain patients use of ARVs for treating CFS. Of the seven who did respond to the anonymous poll (see Figure above for full results):

1 patient said they had asked their physician for a prescription for ARVs and their doctor had not provided one. Many CFS clinicians such as Dr. Nancy Klimas have also chosen not to give patients ARVs, preferring to wait for scientific back up. She said, “I doubt that there are many CFS patients on antiretrovirals. Most doctors asked their patients to wait until the XMRV observations were confirmed and clinical trials begun. In my own practice very few were tested and I wrote no prescriptions for antiretrovirals, I think this was the norm.”

3 patients responded that they have ‘thought about taking ARVs, but are waiting on the science’. Science that may not proceed now that the main proponent of XMRV in CFS, Dr. Judy Mikovits, has been fired from the Whittemore Peterson Institute (WPI).

A few users left comments, with one expressing concern saying, “Why should we participate in this survey? Why give those who don’t want us to take ARV’s any ammunition?

Even though the response rate was low, it seems that there is no alarming use of ARVs to treat CFS, as may be interpreted after reading the NY Times Article. We plan to run the survey on Cure Talk as well and update the responses.

In the meanwhile, it will be interesting to see what happens to the remainder of the $1.6 million dollar R01 grant from the National Institute of Allergy And Infectious Diseases awarded in September 2009 to Dr. Mikovits group for research into XMRV and CFS. Since, Dr. Mikovits is listed as the principle investigator; now that she no longer works for the WPI , the WPI may have to sign-off on the money – something they appear to be unwilling to do. Stay tuned as we bring more details on this ongoing story.

Thank you for this brilliant article. I was one of the people in this poll who picked that we are waiting for more science. This is the general approach of patients. The number of patients that are taking ARVs in exceedingly small from what i can tell, but the press and certain scientists have been making sensationalist claims about it. Keep up the good work!

How about doing an article on the decades-long war that CDC, NIH and a small band of UK psychiatrists have been waging on ME science and patients?

for more info pls see Prof. Malcolm Hooper’s excellent works- meactionuk.org.uk/ and Hillary Johnson’s blog and book Osler’s Web- oslersweb.com

m moore

dear kate, thank u for taking the time to write on this politically “HOT” subject. 1st time i have read u’r work & u seem very ‘fair’…Thank God !! keep it up, i have been sick for over 25yrs+plus a +xmrv’er. there is soooooo much that is ‘harrififing, about this story thats really about “genociod” (sorry-sp-bad -brain fog) keep up u’r reserch, u may break the story of the ‘century’ many Blessing’s to u …………… anangelonduty